A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: ORR(CR+PR) and PCR
研究概览
简要总结
It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer.
详细描述
It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is available on Zoladex in neoadjuvant treatment for breast cancer In our departments, neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to investigate whether adding Zoladex into neoadjuvant CEF could further improve results in hormone responsive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Pathological confirmation of breast cancer
- •Tumor stage(TNM):T2-4bN0-3M0
- •ER(+) and/or PR(+).
- •Premenopausal woman.
- •Age≥40 years
- •Measurable disease as per RECIST criteria
- •Karnofsky≥70
- •Labratory criteria:
- •PLT≥100*109/L
- •WBC≥4000/mm3
- •HGB≥10g/dl
- •ALT and AST<2*ULN
排除标准
- •Presence of metastatic disease.
- •Inflammatory breast cancer.
- •Bilateral breast cancer.
- •previous chemotherapy or hormonal therapyfor current breast neoplasm.
- •other malignant tumor (concurrent or previous).
- •Pregnant woman.
- •Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
- •Any severe systemic disease contraindicating chemotherapy.
结局指标
主要结局
To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: ORR(CR+PR) and PCR
次要结局
- To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: CBR, downstaging rates in tumor size and axillary lymph node -To evaluate the safety of concurrent Zoladex and CEF as neoadjuvant regimen